CN105764452A

CN105764452A - Controlling a size of a pylorus

Info

Publication number: CN105764452A
Application number: CN201480063247.6A
Authority: CN
Inventors: 詹姆斯·E·科尔曼
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-11-20
Filing date: 2014-11-20
Publication date: 2016-07-13
Anticipated expiration: 2034-11-20
Also published as: CA2928096A1; CN105764452B; US10646226B2; US20150142111A1; US20180098770A1; CA2928096C; EP3071158A1; US9855048B2; WO2015075149A1

Abstract

Systems and methods are provided for reversibly controlling a size and/or restricting the movement of a body orifice, such as a pyloric opening, using an implantable device configured to allow a distance between opposed ends thereof to be adjusted. A device is provided having attachment members and a connector portion extending therebetween and configured such that a size of the pyloric opening is decreased upon the implantation of the device. The connector can be adjustable to allow a size of the pyloric opening to be adjusted after it has been restricted. The connector can include two or more bridge portions having different lengths such that cutting a first bridge portion can increase the distance between the attachment members so as to increase the size of the pyloric opening. To revert to a natural size of the body orifice, the entire connector can be cut or otherwise broken and/or removed.

Description

Control pylorus size

The cross reference of related application

This application claims the U.S. Provisional Patent Application number 61/906 being entitled as " Srgery grafting device, system and method " submitted on November 20th, 2013,727 and the U.S. Patent Application No. 14/547 being entitled as " control pylorus size " submitted on November 19th, 2014, the rights and interests of 557, its full content is cited and is incorporated herein.

Technical field

The present invention is provided to control the system and method for the size of body orifice such as pyloric ostium.

Background technology

Obesity rates grows steadily in the U.S. and other country.People by fat and many severe disease such as heart diseases, diabetes, joint disease, rising cancer morbidity or even death link together.

Fat can use various causes that the method lost weight is treated.Bariatric surgery and other similar approach have been used to assist in patient's fat-reducing.But, such operation is usually invasive and can be associated with many complication and risk.Additionally, cholelithiasis and malnutrition can be there is in patient.It addition, some common bariatric surgeries such as gastric bypass process is irreversible.And, operating successfully depend on that patient makes huge lifelong change, such as the absorption of edible special foods and vitamin and some drugs.If patient does not comply with required life style adjustment, then surgical outcome may give a discount and be likely to cause health complications.

Thus it still remains a need a kind of method that more effective and invasive accelerated loss of weight is not strong.

Summary of the invention

The invention provides the various method and apparatus controlling port size.In one embodiment, the device provided have be configured to be combined with the first deployable implant the first attachment, be configured to the second attachment being combined with the second deployable implant and the connector being connected between the first attachment and the second attachment.This connector can include having the first length so that the first attachment and the second attachment keep the Part I of first distance and have the Part II of the second length more than the first length.Described Part I is configured to be cut off so that described first attachment and the second attachment keep at a distance of the second distance more than the first distance.

Although described device can have various configuration, but in one embodiment, at least one in described first attachment and the second attachment can be ring.Such as, the first attachment can be the form forming the first ring in the first end of this connector, and the second attachment can be the form of the second ring forming the second end at connector.This connector also alterable, in one embodiment, this connector can include making the first attachment and the coupled elongated ridges of the second attachment.Part I can be formed by a part for elongated ridges, and Part II can include the opposite end being connected to this elongated ridges at the opposite end of Part I.In other side, Part I can be positioned between the opposite end of the Part II of connector.This connector may also comprise the Part III with the 3rd length more than the second length.Part II is configurable to be cut off, so that the first attachment and the second attachment keep at a distance of the 3rd distance more than second distance.

Thering is provided a kind of system controlling port size in another embodiment, this system includes the first implant being configured in tissue to be implanted, the second implant being configured in tissue to be implanted and has the first end being connected to the first implant and be connected to the connector of the second end of the second implant.This connector can include the first bridge part that is that extend between the first end and a second end and that have the first length.First bridge part is configurable to keep the first implant and the second implant first distance.That this connector is additionally may included between the first end and the second end to extend and second bridge part with the second length more than the first length.Second bridge part is configurable to keep the first implant and the second implant second distance.First bridge part is configured to be cut off to allow the first implant and the second implant to move to second distance from first distance.

In some scheme, this connector can include at least one ring for accommodation one of the first implant and the second implant of sliding being formed thereon.Such as this connector can include formation and at first ring for accommodation the first implant of sliding of its first end and form the second ring for accommodation the second implant of sliding at its second end.

In other embodiments, this device may be included in the 3rd bridge part extending and having the 3rd length more than the second length between described first end and the second end.Described 3rd bridge part is configurable to keep the first implant and the second implant at a distance of the 3rd distance.Along with described first bridge part is cut off, described second bridge part is configurable to be cut off to allow the first implant and the second implant to move at a distance of the 3rd distance from second distance.In other side, described first bridge part can be positioned between the opposite end of the second bridge part.

In another embodiment, a kind of method that size controlling body orifice is provided, the method includes: by the first deployable implant in the first position implanting tissue of first side in aperture, by the second deployable implant in the second position implanting tissue of second side in described aperture, thus the first bridge part of the connector extended between the first implant and the second implant keeps primary importance and second position first distance, and cut off the first bridge part so that the second bridge part of described connector keeps primary importance and the second position at a distance of the second distance bigger than the first distance.The method is additionally included in after cutting off the first bridge part and cuts off the second bridge part so that the 3rd bridge part of connector keeps primary importance and the second position at a distance of threeth distance bigger than second distance.The method cuts off the 3rd bridge part after may additionally include cut-out the second bridge part, thus implant is not kept at a distance between the primary importance in aperture and the second position.

In other scheme, implant the first implant and include launching the nearside spademan of the first implant and distally spademan to engage tissue therebetween, implant the second implant and include launching the nearside spademan of the second implant and distally spademan to engage tissue therebetween.In other embodiments, combined by corresponding first attachment and the second attachment, the first connector and the first implant and the second implant.First deployable implant is delivered to body orifice together with connector before being additionally included in implantation by the method, and this connector is connected to the first deployable implant and is arranged in the delivery rod being connected to the first deployable implant.The method is additionally included in the 3rd position in aperture by the 3rd deployable implant implanting tissue, thus the first bridge part of the second connector extended between the second implant and the 3rd implant keeps the 3rd distance between the second position and the 3rd position.

Accompanying drawing explanation

Above-described embodiment will be more fully understood from from described in detail below in conjunction with accompanying drawing.Accompanying drawing is not intended to be drawn to scale.For clarity sake, it not that each parts are in the drawings with labelling.In the accompanying drawings:

Figure 1A is the axonometric chart of an embodiment of device, and this device has the connector being in the initial configuration for keeping the first distance between attachment；

Figure 1B is another axonometric chart of the device of Figure 1A, and this device has the connector being in the second configuration for keeping second distance between attachment；

Fig. 1 C is another axonometric chart of the device of Figure 1A, and this device has the connector being in the 3rd configuration for keeping the 3rd distance between attachment；

Fig. 2 is the three-dimensional side view of the device of Figure 1A, and this device has and is attached to the first deployable implant thereon before the first implant launching；

Fig. 3 is the three-dimensional side view of the assembly of Fig. 2, and wherein the spademan of the first implant is unfolded；

Fig. 4 is the three-dimensional side view of the device of Fig. 3, is attached to the second deployable implant thereon including before launching the second implant；

Fig. 5 is the three-dimensional side view of the device of Fig. 4, and wherein the first implant and the second implant are all unfolded；

Fig. 6 is the rearview of the device of Fig. 5；

Fig. 7 is the side isometric view of the device according to another embodiment；

Fig. 8 is the side isometric view of the device of Fig. 7, including the first deployable implant and the embodiment being attached to operation instrument thereon before launching the first implant；

Fig. 9 is the side isometric view of the device according to another embodiment；

Figure 10 is the side isometric view of the device according to another embodiment；

Figure 11 A is the schematic diagram of pylorus；

Figure 11 B is the schematic diagram of an embodiment of the method for the size of the pylorus controlling Figure 11 A；

Figure 11 C is another schematic diagram of the method for the size of the pylorus controlling Figure 11 A；

Figure 12 is the schematic diagram of an embodiment of the method controlling pylorus size；

Figure 13 is the schematic diagram of another embodiment of the method controlling pylorus size；

Figure 14 is the schematic diagram of another embodiment of the method controlling pylorus size；

Figure 15 is the schematic diagram of another embodiment of the method controlling pylorus size；

Figure 16 A is the schematic diagram of an embodiment of the method that implant is delivered to implantation site；

Figure 16 B is another schematic diagram of an embodiment of the method that implant is delivered to implantation site；With

Figure 16 C is another schematic diagram of an embodiment of the method that implant is delivered to implantation site.

Detailed description of the invention

Some embodiments be will now be described to provide the overall understanding to apparatus as disclosed herein and side's ratio juris.Accompanying drawing illustrates one or more examples of these embodiments.It will be understood by those skilled in the art that apparatus and method especially as described herein and as depicted are non-limiting example and the scope of the present invention is limited only by the claims.Additionally, about shown by an embodiment or described feature can combine with the feature of other embodiments.Intend to contain this amendment and modification within the scope of the invention.

There is provided for treating fat and other associated conditions such as type ii diabetes method and apparatus with the secured fashion of Noninvasive.Especially, described technology make use of pyloric ostium size control device.Pylorus is in the sphincter between harmonization of the stomach small intestinal the first section and duodenum.Pylorus includes two parts, passes to the pyloric antrum of body of stomach and passes to duodenal pyloric canal.Pyloric canal terminates in pylorus aperture or the pyloric ostium that mark harmonization of the stomach duodenum connects.Pylorus allows food walk to duodenum from stomach and control the gastric emptying caused by the contraction movement of harmonization of the stomach pylorus.

The restriction of stomach pylorus relates to shrinking pylorus and increasing food staying the time under one's belt, causes delayed gastric emptying.This can bring out or strengthen patient satiety, thus patient is likely to less want to enjoy overfeeding.This food intake minimizing and calorie consumption reduce and may finally contribute to fat-reducing and promote Bariatric.

Method disclosed herein and device can be used for controlling pyloric ostium size, and namely the food that allows of pylorus arrives the size of orifice area of small intestinal from stomach through it.This device can be used for shrinking pylorus hole, if it is desired, puts eurypylorus subsequently.Additionally, the peristaltic action that method described herein and device can be used for reducing in pyloric ostium region shifts through aperture with the food that slows down.Use the method for described device very simple, more weak, more effective than now methodical invasive and can be completely reversibility.Therefore, if without limiting pyloric ostium size, then this device can be operated so that pyloric ostium recovers to its natural size and becomes to open wide completely.Although it will be recognized by those of ordinary skill in the art that method described herein and device are for shrinking pylorus, these apparatus and method may be alternatively used for adjusting the size in any aperture.

This device generally can include the connector part being connected between attachment.Attachment is configurable to and the corresponding deployable implant coupling that can be added in tissue.So, this device can be delivered to implantation site at pyloric ostium place or other body orifice place, and once implant is launched, can be maintained at this site by implant.This device can be positioned on opening part, thus connector part strides across opening and is thus used to control opening size.Except adjusting opening size, this device also can slow down or prevent to wriggle, thus the food that slows down shifts through pyloric ostium.The length of connector part can be conditioned to adjust opening size.

Figure 1A-1C illustrates an embodiment of the device 100 for controlling the body orifice such as size of pylorus aperture or pyloric ostium.Shown device 100 includes first attachment the 102, second attachment 104 and is connected to the bridgeware between the first attachment 102 and the second attachment 104 or connector 106 at the first end 103 and second end 105 of connector 106.

As shown in Figure 1A, the first attachment 102 is arranged in the first end 103 of connector 106, and the second attachment 104 is arranged in the second end 105 of connector 106.First attachment 102 is configurable to be combined with the first deployable implant, and the second attachment 104 is configurable to be combined with the second deployable implant.In this embodiment, the first attachment 102 and the second attachment 104 are as shown in the figure in the ring-type or the round that can be removed and slidably receive corresponding deployable implant.Described circle can be made up of various materials and can have various flexibility/stiffness and/or elasticity.In one embodiment, described circle for ease of coordinate the implant of various sizes be flexible and optional be elastic.It is allowed to hold other configuration any of corresponding deployable implant it should be understood that this attachment can have, thus implant can be delivered to when engaging with attachment and be maintained at surgical site.

Connector 106 also can have various configuration.In the embodiment shown, connector 106 has the multiple elongated bridge part extending and having different length between attachment 102,104.Such as shown in Figure 1A, connector 106 includes having the Part I 108 of the first length, have the Part II 110 of the second length and have the Part III 112 of the 3rd length.In this embodiment, Part I 108 is the shortest, and Part II 110 is longer than Part I 108, and Part III 112 is the longest in part 108,110,112.As shown in figs. ia-1 c, Part I 108 can be fixedly attached to the first attachment 102 and the second attachment 104.In certain embodiments, Part I 108 can be integrally formed with attachment 102,104.But Part I 108 can be attached to attachment 102,104 in any way as suitable.The clamping element 114,116 of the first end 103 and the second end 105 place that Part II 110 and Part III 112 can pass through to be positioned at connector 106 is connected to Part I 108.In the embodiment shown in Figure 1A-1C, Part II 110 and Part III 112 are connected to Part I 108, are rather than directly to attachment 102,104.It will be appreciated that, in other embodiments, Part II 110 and Part III 112 can additionally or alternatively be connected directly to attachment 102,104.

In certain embodiments, one or more in Part I 108, Part II 110 and Part III 112 can be made up of single elongate articles (such as suture, cord, tinsel or other part any).Additionally, the one or more length in Part I 108, Part II 110 and Part III 112 can be adjustable, to adapt to the different natural size in anatomical features such as aperture to be controlled of patient, the size zoomed out and other factors.Therefore, before device 100 is delivered object, surgeon or other medical professional are operatively connected part 106, make Part I 108, Part II 110 and Part III 112 have Len req.Such as clamping element 114,116 is configurable to released to allow the one or more length in described part 108,110 and 112 to be conditioned, and is clamped subsequently before device 100 launches.But in certain embodiments, namely device 100 can manufacture by form according to expansion, thus without any size of device is done further adjustment before this device is inserted into health.

Connector 106 is configurable to play and keeps attachment 102,104 to be separated by the bridgeware effect of specific range.In certain embodiments, in order to regulate the spacing of attachment 102,104, the bridge part 108,110,112 of connector 106 can be cut off, disrumpent feelings or otherwise change.It is appreciated that, the connector 106 of device 100 is only exemplified in this article and includes three bridge parts 108,110,112, because connector 106 can include having any appropriate number of bridge part (two, four, five etc.) of any suitable configuration and length, this is because embodiment is not limited in this respect.Part I 108, Part II 110 and Part III 112 can have different length.According to a non-limitative example, each part can have the length within the scope of from about 1 millimeter to about 10 millimeters.

In certain embodiments, the length of the longest part of connector 106 is smaller than the natural size wanting the pyloric ostium with device 100 control or other opening, such that it is able to restriction opening.The length of part 108,110,112 can be selected to make connector 106 that pylorus can be maintained at local closure state, and this allows the food of certain size to transition into small intestinal, and makes the food of large-size be detained under one's belt.In this way, it is possible to different modes controls gastric emptying rate, for instance according to desired fat-reducing target, patient characteristic and any other factors.

In certain embodiments, two or more parts of connector 106 can have equal length.Be also to be understood that the citing of the concrete shape of the Part I 108 in Figure 1A-1C, Part II 110 and Part III 112 illustrates, and part 108,110,112 can have any suitable dimension and configuration.

The Part I 108 of connector 106, Part II 110 and Part III 112 can be made up of the identical or different material for forming attachment 102,104.In certain embodiments, the bridge part 108,110,112 of connector 106 and/or other component of device 100 such as attachment 102,104 can be made up of pliable and tough durable conformable material, when device 100 is maintained in patient body aperture, this material can be cut off by suitable surgical instruments.Although this material can be stiff, but this material can be elastic in other embodiments.Such as, each connector part can have different extent of elasticity to produce desired length when its tension.

Except being cut off or replace cutting off ground, one or more in part 108,110,112 be manufactured into they can by disrumpent feelings, break or otherwise change, thus their integrity is destroyed or interrupts.This material is configurable to cut-off or disrumpent feelings with lossless manner, thus when one or more cut-off in part 108,110,112, the free end of (multiple) cutting part being consequently formed will not cause wound or any irrational inconvenience to patient.This material can be such as staples, and it can be made up of polymer, natural fiber, their any combination or other suitable material any such as rustless steel, titanium and/or noble metal.In certain embodiments, one or more in part 108,110,112 can be biodegradable.Such as, one or more in part 108,110,112 can be that selectivity is biodegradable, and as they can decompose to control body orifice size with different speed, this can select in any suitable manner.

In using, one or more in the part 108,110,112 of connector 106 are configurable to be cut off, disrumpent feelings or remove to change the spacing of attachment 102,104.Such as in the configuration of the device 100 shown in Figure 1A, when all three part 108,110,112 is complete, attachment 102 and 104 keeps first distance d₁.First distance can be depending on the length of Part I 108, and it is the shortest part of connector 106.Such as, the first distance can be equal or substantially equal to the first length of Part I 108.

When Part I 108 is cut off, attachment 102 and 104 can keep at a distance of more than the first distance d₁Second distance d₂, as shown in Figure 1B.Second distance d₂Can being equal or substantially equal to the length of part 110, it is the second part grown of connector 106.So, the spacing of attachment 102,104 can increase, as shown in Figure 1B illustrates.It is it desired to increase further the spacing of attachment 102,104, then part 110 can similarly be cut off or otherwise disrumpent feelings, thus the spacing of attachment 102,104 becomes dependent on the length of Part III 112, Part III is the longest part of connector 106.Especially as shown in Figure 1 C, when Part I 108 and Part II 110 both of which are cut-off, attachment 102,104 can keep the 3rd distance d apart depending on Part III 112 length₃, this is to maintain the unique portion that attachment 102,104 links together now.If body orifice size need not be limited, then Part III 112 also can be cut off or disrumpent feelings, thus port size is no longer applied any restriction by device 100.Device 100 is used such as to shrink the method for pyloric ostium as described in more detail below.

Device 100 is configurable to be combined with one or more deployable implants.Fig. 2 illustrates the first deployable implant 202 being in unexpanded configuration, sentences control port size according to some embodiments for device 100 is anchored at body orifice.It will be understood to those of skill in the art that any anchoring piece can be used for device 100 is fixed to tissue.nullShould be appreciated that，Can with described technology and the device for delivering and launch implant、Implant 202 and other implant any that system and method (as being used for delivering to (multiple) implant the introducer of health) is used in combination can include any component，It is configured at least such as December in 2009 the published US Patent No. 7 being entitled as " Wound closure devices and method " on the 1st,625,392、The US Patent No. 8 being entitled as " stomach shunting device and process " that on June 12nd, 2012 is published,197,498、Described in the U.S. Patent Application Publication No. 2009/0105733 being entitled as " anastomosis apparatus and method " that on October 22nd, 2007 is submitted and December in 2011 the submitted U.S. Patent Application Publication No. 2013/0165963 being entitled as " apparatus and method for blocking or promoting fluid to flow " on the 21st，The full content of every section of document is cited and is incorporated herein.

Fig. 2 illustrates the first deployable implant 202, and it has near-end 206a and far-end 206b and is detachably connected to guiding piece 204 at near-end 206a." near-end " used herein refers to one end or the part of the hands controlling the operation of said apparatus such as implant 202 near operator (such as surgeon)." far-end " refers to operator and near one end of surgical sites or part.As in figure 2 it is shown, guiding piece 204 can be elongated tubular and the part that could be for being delivered to implant 202 delivery components of implantation site.As further shown in Figure 2, implant 202 can include the ring 208 that is arranged in its near-end 206a place.Implant 202 (such as slidably) can be connected to attachment 102 at its near-end 206a place.Such as, before being delivered and being fixed to tissue, implant 202 can in its far-end 206b situation lower slider through the circle of attachment 102, thus this circle reclines, ring 208 is to prevent implant 202 from travelling through attachment 102 further.

Implant 202 can have substantially elongated body 212, and this body has near-end 205a and far-end 205b.Implant 202 also includes being configured to launch to engage the portions of proximal 214a and distal part 214b organized therebetween.As shown in the not deployed implant 202 of Fig. 2, portions of proximal 214a and distal part 214b all includes multiple slit 216a, 216b formed in which, and slit is configured to allow for a part for slender tube body 212 and radially dilates between slit 216a, 216b multiple.The middle part 218 between portions of proximal 214a and distal part 214b of slender tube body 212 is configurable to be positioned in the way of crossing over the tissue wall being added with implant 202 when implant 202 is launched.Middle part 218 can have regular length or adjustable-length.Such as the length at middle part 218 can change to adapt to tissue wall thickness.

Slit 216a, 216b in portions of proximal 214a and distal part 214b can stretch to any direction, and each several part 216a, 216b can include any number of slit.In certain embodiments, when slit 216a, 216b is configured to when body 212 axial-rotation and/or compresses, some part at described slender tube body 212 between slit 216a, 216b can outside stretching, extension from the central axis A of body 212.Owing to part 214a, 214b outwards stretch, therefore in portions of proximal 214a and distal part 214b, it is each formed with one or more alar part to engage tissue therebetween.

In the embodiment shown in Figure 2, slit 216a, 216b is generally S-shaped.Slit 216a, 216b can along slender tube body 212 longitudinal extension in the proximal-distal direction and they can around slender tube body 212 axially spaced-apart.In certain embodiments, the slit 216b in distal part 214b can extend in a first direction around the circumference of slender tube body 212, and the slit 216a in portions of proximal 214a can extend along opposite second direction around the circumference of slender tube body 212.Body 212 can be allowed to rotate in the first direction for this configuration so that only one of which circumferentially extending in portions of proximal 214a and distal part 214b, and rotates another circumferentially extending made in portions of proximal 214a and distal part 214b subsequently in a second direction.

In the implant 202 pre-deployment configuration shown in Fig. 2, the diameter of slender tube body 212 allows in its inner chamber being configured to fit within tissue or opening, such as the inner chamber through stomach and/or intestinal.Body 212 is further configured to be assemblied in the guide sheath for inserting health guide 100 or other apparatus.

As in figure 2 it is shown, implant 202 can include conical guide portion 210, it extends from the far-end 205b of body 212.The distal tip 220 being configurable to needle point or similar sharp features can be distally extending from the far-end 211 of targeting part 210.Distal tip 220 can be used for piercing tissue to produce the opening for implant 202 being inserted, and targeting part 210 can distad be tapered to help implant 202 to insert the tissue pierced through by distal tip 220.

In certain embodiments, distal tip 220 can include the suitable surface character that contributes to its puncturing tissue purposes.Such as, distal tip 220 can have the part extending past distal tip 220 or most screw thread.Distal tip 220 can be attached to targeting part 210 at the far-end 206b of implant 202.Distal tip 220 is connectable to the one or more component (not shown) being located in body 212.In certain embodiments, distal tip 220 is configurable to the part preventing the occlusion that fluid flows through body 212 from can be maybe occlusion, such as described in December in 2011 the submitted U.S. Patent Application Publication No. 2013/0165963 being entitled as " apparatus and method for blocking or promoting fluid to flow " on the 21st, its full content is cited and is incorporated herein.

In implant 202 after implantation site is inserted into tissue, portions of proximal 214a and distal part 214b can be extended to form the nearside alar part 314a shown in Fig. 3 and distally alar part 314b.In embodiment shown in Fig. 2 to Fig. 6, slit 216a, 216b are configurable to portions of proximal 214a and distal part 214b and are respectively formed two groups of alar parts.In one embodiment, portions of proximal 214a and distal part 214b is respectively formed two groups of eight alar parts.It should be apparent that, may be structured to form any amount of alar part according to the portions of proximal of the implant of some embodiments and distal part, these alar parts can be aligned with each other or be radially staggered, because described embodiment is not limited in this respect.

Fig. 3 illustrates, in deployed configuration, the portions of proximal 214a of implant 202 extends and forms nearside alar part 314a, and distal part 214b extends and forms distally alar part 314b.Alar part 314a, 314b are formed by the material between slit 216a, 216b, and along with outer slender bodies 212 rotates and/or compresses, this material outwards deforms.Alar part 314a, 314b can concurrently form or successively be formed, for instance by launching distally alar part 314b before nearside alar part 314a.But in certain embodiments, nearside alar part 314a can be previously formed being formed distally alar part 314b.

Alar part 314a, 314b in implant 202 can be formed by rotating and/or compress this device 202.Although various technology can be used for launching and activating this device 202, in certain embodiments, implant 202 is removably attached to operating mechanism, and operating mechanism is suitable to implant 202 introduces health and is suitable to apply axial force and revolving force to slender tube body 212 so that the local of slender tube body 212 stretches out.Fig. 2 illustrates that guiding piece 204 is connectable to the bar 209 of operating mechanism (not shown).In one embodiment, nearside alar part 314a and distally alar part 314b can include being formed along with alar part and grasping the tissue engaging mechanisms of tissue.Alar part 314a, 314b can by such as compressing portions of proximal 214a and distal part 214b along with portions of proximal 214a and distal part 214b rotates formed to form alar part.

Body 212 can be made up of the various materials including absorbable material and nonabsorable material.In one embodiment, implant 202 is made (i.e. the insignificant deformation of elastic part) by the deformable material standing plastic deformation.As non-limitative example, exemplary material include any can re-absorption (such as biocompatibility and/or Bioabsorbable) material, for instance comprise titanium (and titanium alloy), magnesium alloy, rustless steel, polymeric material (artificial and/or natural), shape-memory material asPottery etc..By adding X-ray visible material such as ferric oxide particles, rustless steel, titanium, tantalum, platinum or other suitable equivalent any, usual radiopaque material such as magnesium alloy can be enhanced and to become X-ray visible.In certain embodiments, also alternately or alternatively it is used to form including other material of non-permeable material such as polyethylene terephthalate and polyvinylidene chloride and semipermeable materials such as polylactic acid and/or is coated with body 212.

In using, as in figure 2 it is shown, there is the device 100 being attached to the implant 202 being in pre-deployment configuration thereon endoscope or laparoscopically mode can be inserted into patient body.The delivery system (Fig. 2) such as in the proximal end of bar 209 with guiding piece 204 can be used to the device 100 engaged with implant 202 is sent into implantation site.It is to be understood that device 100 and implant 202 can be delivered to implantation site in any way as suitable.Device 100 can be engaged to implant 202, or alternatively, in some instances, device 100 and implant 202 can be delivered to implantation site respectively.

Although not being illustrated in figs. 2-6, but in certain embodiments, can be used for this device of more than one is anchored to tissue for the first deployable implant or main deployable implant that device such as device 100 is anchored to tissue.Such as first deployable implant 202 may pass through the attachment of the more than one of this device such as the ring of the ring 102 that is similar in Fig. 2 or other type of (multiple) attachment, thus makes the device including these attachments connect with implant 202.In the embodiment shown in Figure 2, the ring of more than one can be placed in above the near-end 205a of body 212 to recline ring 208.So, when the first implant 202 is unfolded, the device of more than one (as two, three or more) be anchored to tissue.Each device that identical main implant is anchored is used to can be used for restriction pyloric ostium size.Such as, described device can position in the way of extending across pyloric ostium at least partly, and each device can use respective second implant or secondary implant to be fixed on each different positions near pyloric ostium.Secondary implant can be fixed to tissue at the opposite side of the position of fixing main implant.Use the first identical implant the device of more than one is anchored to tissue method embodiment as shown in figure 13.

As it has been described above, described technology is particularly well-suited to control pylorus size.Thus, in certain embodiments, implant 202 and device 100 can be delivered to pyloric ostium.Once implant 202 is sent near pyloric ostium, the tip of implant 202 just can be used in pylorus side piercing tissue.Opening in being consequently formed tissue and after desired locations positioning implants 202, implant 202 can be manipulated by so that the portions of proximal 214a and distal part 214b of body 212 extend, thus launching nearside alar part 314a and distally alar part 314b to engage tissue therebetween.In the fig. 3 embodiment, portions of proximal 214a is configured to define the two groups of alar parts being radially staggered toward each other.Similarly, distal part 214b is configured to define the two groups of alar parts being radially staggered toward each other mutually.Nearside alar part 314a and distally alar part 314b can be in alignment with each other, as shown in Figure 3.

In certain embodiments, alar part 314b in distally can be unfolded before nearside alar part 314a launches.Formed in the tissue wall side of pyloric ostium and puncture and after implant 202 is positioned so that the opposite sides that middle part 218 is placed in tissue wall through points of puncture and portions of proximal 214a and distal part 214b, implant 202 can be manipulated by so that distal part 214b launch and at formation distally, tissue wall side alar part 314b.Distally alar part 314b extend after, implant 202 can be manipulated by so that portions of proximal 214a extension and tissue wall opposite side formed nearside alar part 314a.But in certain embodiments, nearside alar part 314a can be unfolded before distally alar part 314b launches.Addedly or alternatively, nearside alar part 314a and distally alar part 314b can concurrently form or concurrently form at least partly, thus at least some of and formation nearside alar part 314a the period forming the period of distally alar part 314b overlap.

No matter nearside alar part 314a and distally alar part 314b is formed in which way and alar part expansion order, owing to alar part is formed, therefore device 100 is anchored to tissue at body orifice such as pyloric ostium place by implant 202.Implant 202 and can be applicable to other implanting device of described technology can in the tissue near implanted pylorus and/or in implanted gastric tissue.

After implant 202 is sufficiently spread out, the operating mechanism (not shown) being connected to guiding piece 204 at nearside can separate with implant 202 and be removed from implantation site, as shown in Figure 3.As a result, implant 202 remains fixed in tissue, engages with device 100 simultaneously.

Reviewing Fig. 2, in the unexpanded configuration of implant 202, most advanced and sophisticated 220 can highlight from the distally of targeting part 210.In certain embodiments, after implant 202 is inserted implantation site, or extending at portions of proximal 214a and distal part 214b and form nearside alar part 314a and distally alar part 314b with before or after engaging tissue therebetween, the basis of most advanced and sophisticated 220 implants 202 being retractable into expansion is internal.Fig. 4 illustrates that most advanced and sophisticated 220 are retracted into the intrinsic implant 202 of implant.So, most advanced and sophisticated 220 ends can be eliminated in the histoclastic probability of implantation site.

Fig. 4 illustrates that its nearside alar part 314a and distally alar part 314b is fully deployed and is attached to the implant 202 of device 100 by attachment 102.In implant 202 after pyloric ostium side is fixed to tissue, another implant i.e. the second implant 402 being in unexpanded configuration also such as can be attached to device 100 by the second attachment 104, as shown in Figure 4.Second attachment 104 can be constituted in the form of a ring, is similar to the first attachment 102, but may be used without other configuration.As shown in Figure 4, the second implant 402 can be similar to the first implant 202 and can with its distal tip 420 through the second attachment 104.

Similar to the first implant 202, the second implant 402 can have slender tube body 412, and this body includes near-end 405a and far-end 405b.As it is shown in figure 5, slender tube body 412 can include the portions of proximal 414a and distal part 414b and the middle part 418 that are respectively provided with nearside slit 416a and distal slit 416b.Distally conical guide portion 410 can extend from the far-end 405b of body 412, and distal tip 420 can be distally extending from targeting part 410.Ring 408 can be located at the near-end 405a place of body 412 and prevents attachment 104 proximad from skidding off implant 402 as backstop.Can being the guiding piece 404 of a part for means of delivery assembly the near-end 406a that is connectable to the second implant 402, means of delivery assembly be configured to implant 402 is delivered to surgical sites.Portions of proximal 414a and distal part 414b may be structured to extension and forms respective nearside alar part and the distally alar part that joint is organized therebetween.

In using, after implant 402 is held by the attachment 104 of device 100, (or size to be controlled other body orifice) the size reduction that device 100 can be applied pulling force so that pyloric ostium.Operating mechanism or be attached to any other appropriate device (Fig. 4) of the detachably connectable guiding piece 404 in device 402 near-end 406a and can be used in the implant 402 that moves up along the side of pyloric ostium diameter, thus the device 100 engaged with implant 402 is pulled over opening to reduce its size.In other words, the second implant 402 make the second implant 402 move apart the first implant 202, thus can be anchored in tissue in the side contrary with the first implant 202 of pylorus.One or more components (such as connector 106 and/or other component) of device 100 can be made up of elastomeric material, thus can be stretched when it is pulled contraction opening timer 100.

After arriving the desired locations of device 100, when device 100 is tightened up, implant 402 can be used to the opposite side piercing tissue relative with the side that implant 202 has been launched at pyloric ostium.Subsequently, implant 402 can be unfolded, thus portions of proximal 414a and distal part 414b extension forms nearside alar part 514a as shown in Figure 5 and distally alar part 514b, this can launch similarly to complete with alar part 314a, 314b.When the suitable gripping device that device 100 is connected to implant 402 is handled, device 100 can be moved, thus around pylorus hole and/or tissue near pylorus hole is folded or gauffer, or be otherwise manipulated to reduce pyloric ostium size.

After implant 402 is fully deployed, the operating mechanism (not shown) and the guiding piece 404 that are connected to guiding piece 404 near-end can separate with implant 402 and be removed from surgical sites, as shown in Figure 5.Although it should be noted that Fig. 5 illustrates distal tip 220,420, but most advanced and sophisticated 220,420 after it is used to pierce tissue regracting (as in the diagram for shown in implant 202), to avoid being likely to the prominent sharp edges that damage is organized.This is useful especially for reducing sensitive organization's wound in gastrointestinal tract.

Owing to the second implant 402 is unfolded after the first implant 202 is launched, therefore device 100 will be positioned in pyloric ostium place, thus connector 106 extends across pyloric ostium and between the first implant 202 and the second implant 402.Thus, device 100 is fixed in tissue by implant 202,402 in the corresponding opposite sides of opening.So, the natural size in pylorus hole is reversibly reduced and can be kept the desired size of opening by the connector 106 of this device 100.Pyloric ostium can keep any persistent period in part opens state, may return to complete opening-wide state when needed.

It should be understood that deployable implant 202,402 is not necessarily in the implanted tissue of corresponding opposite sides of pyloric ostium.For controlling pyloric ostium size, deployable implant 202,402 (or being other deployable implant any of same purpose) can any suitable relevant position near pyloric ostium implanted.

Fig. 6 be shown in the nearside alar part 314a and distally alar part 314b of the first implant 202 at least one be unfolded and the rearview of device 100 when at least one in the nearside alar part 514a and distally alar part 514b of the second implant 402 is unfolded.When the portions of proximal 214a radial expansion of the first implant 202 forms nearside alar part 314a, nearside alar part 314a can be directed at distally alar part 314b to help to be attached to tissue.Equally, the nearside alar part 514a of the second implant 402 can be directed at distally alar part 514b, as shown in the example of Figure 6.It is to be understood that the nearside alar part of implant and distally alar part can be radially staggered toward each other.

Although further, it should be understood that Fig. 4-6 illustrates that essentially identical implant 202,402 will be connected to device 100, but implant 202,402 can be various configuration.Can addedly or alternatively use and be configured to be held and in implanted tissue with any kind of extendable device that holding means 100 is in place by the attachment of device 100, because embodiment is not limited in this respect.Implant 202,402 may be structured to form any appropriate number of alar part, and the alar part quantity between implant can be identical or different, and nearside alar part and distally alar part can align each other or stagger.Additionally, only citing illustrates that first attachment 102 holds implant 202, because attachment 104 or main implant can be used as so that device 100 is anchored to tissue.

After implant 202,402 is launched, device 100 can pass through to be connected to implant 202,402 by attachment 102,104 and be maintained at surgical sites place, as shown in Figure 5.Implant 202,402 can be unfolded connecing juxtapyloric diverse location in tissue, thus the connector 106 of device 100 is at least partially across limited aperture.Therefore connector 106 will set orifice diameter.But in some instances, being arranged to the mode in health according to device 100, connector 106 can position in the way of not passing through aperture.

As it has been described above, the part 108,110,112 of connector 106 is configurable to the length of the Part III 112 grown most less than port size (such as diameter or other size), this port size can be controlled by device 100.Should be appreciated that, only citing illustrates three parts 108,110,112, because connector 106 can include any appropriate number of different length part (such as two, four, five etc.), it can be used to reduce and sequentially subsequently (or otherwise) increases body orifice size.If being no longer desire to restriction body orifice size (as when loss of weight is expected in Bariatric success and realization or in what its situation in office), the any remaining part not yet cut off of all parts 108,110,112 or connector 106 can be cut off or otherwise disrumpent feelings, make aperture recover to its natural size, aperture is not imposed any restriction.

Fig. 7 and Fig. 8 illustrates another embodiment that can be used to control the device 700 of the size of body orifice such as pyloric ostium.Device 700 is configurable to be combined with the first implant and the second implant, and the first implant and the second implant can be similar to above-mentioned first implant the 202, second implant 402 in certain embodiments.Fig. 8 illustrates the first deployable implant 802 can being combined with device 700.Device 700 can be configured to be arranged on the means of delivery assembly including the first implant 802 and surround this means of delivery assembly.

As shown in Figure 7 and Figure 8, device 700 generally includes the elongated ridges 702 with near-end 702a and far-end 702b.At least one attachment is formed on ridge 702 or is connected with this ridge so that device and implant connect.In the embodiment shown, far-end 702b forms the first attachment 701 being configured to directly be combined with the first implant, and device 700 includes the second attachment 709 for being combined with the second implant.First attachment 701 and the second attachment 709 limit the connector part 704 that extends betwixt for remaining attached to the distance between the first implant and second implant of attachment 701,709.Connector part 704 can include bridge part for allowing the spacing of implant is adjusted.This device may also comprise the 3rd attachment 711, and it is shown disposed on the near-end 702a of ridge 702 for being connected to the 3rd implant, as will be described in detail.

Attachment 701,709,711 can have various configuration.In the embodiment shown, the first attachment 701 is only the distalmost end 702b of ridge 702, and it is configurable to directly be combined with implant, as used bonding agent or other attachment technology known in the art.But selectively, attachment 701 can be that ring or other component form connect and integrated implant.Second attachment 709 and the 3rd attachment 711 also can have various configuration, but are illustrated as removable and that slidably receive corresponding deployable implant ring or circle.Second attachment 709 and the 3rd attachment 711 are also configurable to hold the means of delivery through it, as shown in Figure 8, deliver the implant equipped with device 700 to allow means of delivery to be used for.Ring can be made up of various materials and can have various degrees of pliability/rigidity and/or elasticity.It should be understood that attachment can have other configuration any.

Connector part 704 also can have various configuration.In the embodiment shown, connector part 704 has between attachment 701,709 and has multiple brackets of different length.Especially connector part 704 includes the short bracket 706 along ridge 702 formation and elongate bracket 707.But this device can include any amount of bracket.Bracket is preferably arranged for and mutually strides across, and each bracket has the size of increase relative to the bracket being arranged there between.Each bracket especially can have generally U-shaped configuration, and U-shaped configuration has the opposite end being connected to ridge 702.As it can be seen, short bracket 706 includes the first end 706a and the second end 706b that are connected to ridge 702, elongate bracket 707 similarly includes the first end 707a and the second end 707b that are connected to ridge 702.The first end 706a and the second end 706b of short bracket 706 corresponding position between the first end 707a and the second end 707b of elongate bracket 707 is connected to described ridge.As a result, bracket 706,707 is connected to ridge 707 and forms three bridge parts of connector 704.First bridge part 705 of ridge 702 is particularly formed between the first end 706a of short bracket 706 and the second end 706b, and the first bridge part 705 has the first length.Short bracket 706 limits second bridge part with the second length, and the second length is equal to the second bridge part length measured along the bridge part between end 706a, 706b.Elongate bracket 707 limits the 3rd bridge part with the 3rd length, and the 3rd length is equal to the 3rd bridge part length measured along the bridge part between end 707a, 707b.Therefore the first bridge part 705 is the shortest, and the second bridge part (i.e. bracket 706) is longer than the first bridge part 705, and the 3rd bridge part (i.e. bracket 707) is the longest in these parts.

Bracket 706,707 can be integrally formed with ridge 702, or they can be attached to ridge 702 in any way as suitable.Bracket 706,707 can extend from ridge 702 along reciprocal both direction as shown in the figure, or they can be all located at the same side of ridge.In the embodiment shown, bracket 706,707 is respectively provided with U-shaped or semi-circular configuration.It will be apparent, however, to one skilled in the art, that bracket 706,707 can have any size and/or shape to form the bridge part with different length of connector 704.Additionally, device 700 can comprise more than the bracket of two and/or has the component of other size and dimension any that can form any appropriate number of bridge part.

As it has been described above, device 700 can include the 3rd attachment 711 being positioned at the most proximal end 702a of ridge 702.In certain embodiments, not using the second attachment 709, the 3rd attachment 711 is alternatively used for being combined with the second deployable implant.In such an embodiment, device 700 can be considered as the connector part 704a having and extending to the 3rd attachment 711 from the first attachment 701.Therefore, the 3rd attachment 711 can be combined with the second deployable implant, for instance when expectation reduce larger open (or major part of opening) even if size so that opening size reduces but when connector 704 length is still not enough to stride across opening.Alternatively, when utilizing connector 704a that opening is restricted to smaller extent compared with the situation utilizing connector 704 to make the opposite sides of opening draw closer together, the 3rd connector 711 can be used.Although Fig. 7 and Fig. 8 is not shown, but device 700 can only include an attachment (such as 709 or 711) or include the attachment more than two, and different attachments can be used for mating with the second implant under various circumstances.

Should be understood that device 700 can have appropriate number of any feature that is that be connected to ridge 702 and that have any suitable configuration and size.Such as a modification, device 700 can only include one of bracket 706,707.As another modification, device 700 can include one or more brackets with closed circle cross section, and closed circle cross section can have the cut portion of any suitable shape.The size of feature, configuration and quantity may be selected to and can control pyloric ostium increasing size according to patient profiles, loss of weight progress and any other factors.

In using, the connector part 704 of device 700 can be shaped as the effect of the bridgeware making attachment 701,709 maintenance predetermined distance.Connector 704 includes three bridge parts as shown in the figure, namely the first bridge part 705, be also referred to as the short bracket 706 of the second bridge part 706 and be also referred to as the elongate bracket 707 of the 3rd bridge part 707 hereinafter hereinafter.When device 700 implanted with limit pyloric ostium size and first bridge part the 705, second bridge part 706 and the 3rd bridge part 707 complete time, initial first distance between the attachment 701,709 mate with the first implant and the second implant respectively will depend upon which (as equal to) the shortest first bridge part 705 length.

Be it desired to increase subsequently port size, then one or more in bracket can sequentially or simultaneously be cut off, disrumpent feelings or otherwise change and make the spacing of attachment 701,709 change.Such as the first bridge part 705 can be cut off the first end 706a and the second end 706b to decontrol short bracket 706 along its length at an arbitrary position, it is allowed to end 706a, 706b divide out.As a result, the spacing of attachment 701,709 is by mobile to the longer second distance such as determined by the second bridge part 706 from the first distance such as kept by the first bridge part 705.Be it desired to increase pyloric ostium size further, then short bracket 706 also can be cut off the first end 707a and the second end 707b to decontrol elongate bracket 707 along its length at an arbitrary position, it is allowed to end 707a, 707b are spaced further apart.As a result, the spacing of attachment 701,709 will move to longer 3rd distance such as determined by the 3rd bridge part 707 from the second distance such as determined by the second bridge part 706.It is undesirable that reduce pylorus port size, big bracket 707 also can be cut off, thus device 700 no longer makes implant keep at a distance from each other, therefore pyloric ostium becomes opening wide completely.(multiple) cut-off parts can optionally be removed from implantation site subsequently.

As it has been described above, device 700 can be used in conjunction with the means of delivery assembly being used for delivering implant.Fig. 8 illustrates the first implant 802 that delivery components can be used to be delivered to implantation site, and delivery components includes elongated tubular guiding piece or the bar 804 with the first implant 802 being removably attachable to its far-end.In certain embodiments, device 700 is configurable to the size and dimension of its applicable elongated tubular guiding piece 804.Therefore as shown in Figure 8, the attachment 709,711 of device 700 is configurable to accommodation guiding piece 804 wherein, and this allows implant 802 to be passed through Wicresoft's mouth and be not subject to the interference of device 700.

As it has been described above, the first implant 802 can be passed through to combine be connected to device 700 at far-end 702b and first attachment 701 of device 700.First implant 802 is configurable to similar to above-mentioned first implant 202 and the second implant 402 and can have the slender tube body including portions of proximal 814a, distal part 814b and middle part 818.Portions of proximal 814a and distal part 814b is configurable to extension and forms corresponding nearside alar part and distally alar part (not shown), nearside alar part and distally alar part joint tissue therebetween, as mentioned above.Distally conical guide portion 810 extends from body distal end, and distal tip 820 is distally extending from targeting part 810.As shown in Figure 8, ring 808 may be provided at body near-end and can have the first attachment 701 of combination fixed thereto.Attachment 701 at the far-end 702b place of device 700 can bonding, weld or be otherwise attached to the first implant 802.It should be understood that the first implant 802 can be combined with device 700 in any other suitable way, including using different types of attachment.

In using, the first implant 802 is delivered to implantation site together with device 700 in unexpanded configuration.In order to the first implant 802 being delivered to implantation site as being sent into pyloric tissue, distal tip 820 can be used in this site piercing tissue.After the first implant 802 is properly positioned at implantation site, being included in means of delivery assembly can be maybe that the operating mechanism of independent suitable instrument can be used for operation the first implant 802 so that portions of proximal 814a and distal part 814b expansion and form nearside alar part and distally alar part.With above in relation to after being similarly constructed alar part described in implant 202,402, guiding piece or bar 804 can separate with the first implant 802, thus the first implant 802 is discharged from delivery components.In the example shown, bar 804 can skid off attachment 709,711.

After the first implant 802 is unfolded, the second implant (not shown) may pass through the attachment 709,711 of device 700 in the lump for device 700 being positioned at appropriate location to control body orifice size.Second implant can to arbitrary implant 202,402 and 802 similar, or it can be configured for the different device being fixed in tissue.In certain embodiments, the second implant can be passed through the second attachment 709 and be inserted into, and after implant is extended in body orifice surrounding tissue, it can remain engaged with this implant.But or make the second implant through the 3rd attachment 711 or form other structure any on device 700.Such as in certain embodiments, the attachment more than two being connected to ridge 702 can be formed at the nearside of bracket 706,707.

As it has been described above, different attachments is optionally used for being combined device 700 with the second implant, according to device 700 relative to the position of pyloric ostium, desired pyloric ostium limited degree, pylorus hole dimension and/or any other factors.Such as, if device 700 positions to cross over pyloric ostium diameter (or widest portion) mode, then the second implant can be through the 3rd attachment 711, and the 3rd attachment is located most distal from the first attachment 701 being combined with the first implant 802.Or, if device 700 is implanted in the way of it misplaces relative to pyloric ostium diameter (or widest portion), then available the second attachment 709 closer to the first implant 802 of the second implant is combined with device 700.Therefore, multiple features of device 700 allow the flexible positioning of device 700 and can allow pyloric ostium constriction in various degree.

When the first implant 802 (Fig. 8) with when being all fully expanded in this unshowned second implant, a part for device 700 can be used to control pyloric ostium size such as the connector part 704 extended between the attachment 701,709 being combined with the first implant and the second implant respectively.In some above-mentioned embodiments, after pyloric ostium has utilized intact device 700 tentatively to be limited, the bridge part 705,706,707 of connector 704 can be cut off, disrumpent feelings, remove or otherwise change and increase pyloric ostium size.This can complete when being implanted at first in implant and device, or now regulate at least one follow-up work process of pylorus size in hope and complete.

Device 700 is made by can bear material that is that stomach shrinks and that can be adjusted to control pylorus bore dia when food is forced into small intestinal.Exemplary materials can include and the above-mentioned material identical for the material manufacturing this device 100 or other material any.

Fig. 9 illustrates another embodiment that can be used for controlling the device 900 of the size of body orifice such as pyloric ostium.Similar to the device 700 of Fig. 7 and Fig. 8, device 900 may be structured to adapt to the size and dimension of the delivery components for the first deployable implant is delivered to tissue.Device 900 may be mounted to that on delivery components (not shown) and available first deployable implant is anchored in tissue.

As it is shown in figure 9, device 900 can include the first attachment 901 and the second attachment 909, the ridge 902 that extends between the first attachment 901 and the second attachment 909 and the bracket 906 with the first end 906a and the second end 906b that are connected to ridge 902.In the embodiment shown, bracket 906 semicircular in shape or U-shaped, but it can be other shape any.By non-limiting example, attachment 901,909 is configurable to ring-type and can be positioned on the opposite sides of bracket 906.As it is shown in figure 9, bracket 906 is placed in the center of ridge 902, the first attachment 901 is positioned at the distalmost end 902b place of the ridge 902 of device, and the second attachment 909 is positioned at the most proximal end 902a place of device 900.

In the embodiment shown, the ridge 902 of device 900 can form the connector 904 of the spacing for controlling attachment 901,909 be fixed to the tissue near pyloric ostium at this device after.This connector plays the function similar to above with respect to the connector described in Fig. 7 and Fig. 8, but only includes single bracket 906.A part for the ridge 902 particularly extended between the first end 906a and the second end 906b of bracket 906 can form the first bridge part 905, and it keeps the first attachment 901 and the second attachment 909 first distance.When the first bridge part 905 is cut off, the first end 906a and the second end 906b of bracket 906 is removable separately, and bracket 906 can limit the second bridge part keeping the first attachment 901 and the second attachment 909 second distance, and second distance is more than the first distance.

In using, first attachment 901 and the second attachment 911 all can combine with corresponding deployable implant (such as above-mentioned any implant 202,402,802), thus when implant is launched, device 900 is anchored to tissue near body orifice such as pyloric ostium.Device 900 can be positioned on pyloric ostium place, thus connector 904 positions at least partially across opening.It will be understood to those of skill in the art that the orientation of device 900 can be contrary, thus the distalmost end 902b of device 900 becomes most proximal end 902a, because above-described embodiment is not limited to device 900 and can be anchored to specific orientation and the position of tissue.

Launching in deployable implant and device 900 with after being fixed to tissue at pyloric ostium place, the spacing of attachment 901,909 can tentatively depend on the length of the ridge 902 extended between attachment 901,909.The connector 904 of device 900 can be subsequently used to regulate pylorus port size.Such as after tentatively limiting pyloric ostium size by intact device 900, the need to, first bridge part 905 can be cut off to increase opening size, thus the spacing of attachment 901,909 increases and becomes dependent on the length of the second bridge part being equivalent to bracket 906.If needing to increase further opening size, it is possible to expand by cutting off bracket 906, thus opening size becomes unrestricted.

It will be understood to those of skill in the art that, device 900 can comprise more than the bracket (such as two, three, four or more) of, thus device 900 can be cut off once, twice or more than twice, regulate body orifice size so in multiple steps.Such as similar to device 700 (Fig. 7), device 900 can include more than one bracket, and it has any longitudinal length and positions in any way along ridge 902.Additionally, device 900 can include any further feature of any size and configuration, it contributes to device 900 being delivered to implantation site and allowing to use in different patients with for different conditions.

Figure 10 illustrates another embodiment that can be used for controlling the device 1000 of body orifice such as pyloric ostium size.Similar to device 700 (Fig. 7 and Fig. 8) and device 900 (Fig. 9), device 1000 is configured to adapt to the size and dimension of the delivery components for the first deployable implant is delivered to implantation site.In order to device 1000 is delivered to implantation site, it can be combined and be installed in the first implant in the delivery components being connected to the first implant near-end.

As shown in Figure 10, device 1000 can include the first attachment 1001 and the second attachment 1009 and the connector 1004 extended between the first attachment 1001 and the second attachment 1009.Connector 1004 can include straight ridge 1003 and be connected to first alar part 1005, second alar part 1007 of arch of ridge 1003, flap portion 1011 and the 4th alar part 1013.As shown in Figure 10, the first alar part 1005 has the first end 1005a being connected to the first attachment 1001 and the second end (not shown) being connected to ridge 1003.Second alar part 1007 has the position identical in the position being attached to ridge 1003 with the second end of the first alar part 1007 but is attached to the first end (not shown) of ridge 1003 at the opposite side of ridge 1003.Second alar part 1007 has at the second end 1007b being attached to ridge 1003 from first end a distance.Flap portion 1011 has the position identical in the position being attached to ridge 1003 with the second end 1007b of the second alar part 1007 but is attached to the first end 1011a of ridge 1003 at the opposite side of ridge 1003.Flap portion 1011 has at the second end 1011b being attached to ridge 1003 from first end 1011a a distance.4th alar part 1013 has the position identical in the position being attached to ridge 1003 with the 3rd end 1011b of flap portion 1011 but is attached to the first end 1013a of ridge 1003 at the opposite side of ridge 1003.4th alar part 1013 has the second end 1013b being attached to the second attachment 1009.Thus, in this embodiment, attachment 1001,1009 is not directly connected to ridge 1003.

The attachment 1001,1009 constituted in the form of a ring all can combine (as passed through to hold implant wherein) with corresponding deployable implant, thus when implant is launched, device 1000 is anchored to tissue near body orifice such as pyloric ostium.Such as the first attachment 1001 can combine with the first implant (such as Fig. 8 shown in but unshowned first implant 802 of Figure 10), and the second attachment 1009 can be combined with the second implant.Device 1000 can so be implanted, i.e. after device 1000 is fixed to pyloric ostium tissue around, and connector 1004 can extend across pyloric ostium at least partly and can be used for regulating the spacing of attachment 1001,1009.

Device 1000 implanted and after limiting pyloric ostium (or body orifice) size, it is it desired to increase subsequently opening size, then ridge 1003 Part I 1018 or Part II 1020 can be cut off or otherwise disrumpent feelings (and/or removing), thus the distance increased between the attachment 1001,1009 being combined with deployable implant.In the embodiment shown, if the Part I of ridge 1,003 1018 is cut off, then the first end of the second alar part 1007 and the second end (only illustrating the second end 1007b) will be allowed to separately, thus increase the spacing of the first attachment 1001 and the second attachment 1009.If the Part II of ridge 1,003 1020 is cut off, then the first end 1011a and the second end 1011b of flap portion 1011 will be allowed to separately, thus increase the spacing of the first attachment 1001 and the second attachment 1009.As all cut-off in fruit part 1018,1020, then attachment 1001,1009 will be moved apart further.

If without limiting body orifice size, then the first alar part 1001 or the 4th alar part 1013 can be cut off so that attachment 1001,1009 is completely separate from each other.It is understood that ridge 1003 can be cut off the spacing to regulate attachment 1001,1009 in the arbitrfary point between tab end.Such as in some instances, the part 1018 of the second alar part 1007 and ridge 1003 all can be cut off so that attachment 1001,1009 is completely separate from each other, in other example, the part 1020 of alar part 1011 and ridge 1003 all can be cut off so that attachment 1001,1009 is separated from each other.It should be understood that be that the point that can be cut off of device 1000 is simply illustrated.

It will be understood to those of skill in the art that device 1000 can include any number of alar part (such as three, five or more) so that device 1000 can be cut off once, two or more times, thus regulate body orifice size in multiple steps.Additionally, device 1000 can include any further feature, such as arbitrary characteristics and other suitable feature of device 700,800.

Figure 11 A-11C schematically shows an embodiment of the method using the device described herein such as device shown in Figure 1A-1C and Fig. 2-6.Figure 11 A is the illustrative examples of the pylorus 1100 with pyloric ostium or opening 1102, and this pyloric ostium or opening are not restricted, thus pyloric ostium 1102 has its natural size.Pyloric ostium is the sphincter with ring or smooth muscle or the formation of valve form, it should be understood that Figure 11 A-11C diagrammatically illustrates pyloric ostium 1102 very much.

Figure 11 B illustrate device 100 can near pyloric ostium 1102 implanted and can be used for control pyloric ostium size.As shown in Figure 11 B, the first deployable implant can be unfolded in tissue in the first each relative side 1104 of pyloric ostium 1102 and the second side 1106 with the second implant 402 with the second deployable implant such as the first implant 202.As mentioned above, device 100 can first pass through expansion the first deployable implant and be anchored in tissue (the first side 1104 as at pyloric ostium 1102), first deployable implant is combined with the attachment of this device, as the first deployable implant 202 is combined with attachment 102.

At device 100 after the first side 1104 is anchored tissue, device 100 is tightened up and is positioned in the way of connector 106 extends across pyloric ostium 1102, as shown in Figure 11 B.Subsequently, the second implant 402 is unfolded and is fixed on the second relative side 1106 of pyloric ostium 1102.So, device 100 is positioned to regulate the size of pyloric ostium 1102.It should be understood that device 100 can first be anchored in tissue in the second side 1106, it is fixed to tissue in the first side 1104 subsequently.Should also be appreciated that, implant 202,402 can be fixed to any position near pyloric ostium 1102, because above-mentioned technology is not limited to any ad-hoc location that implant 202,402 (or other implant any that in addition use or replacement use) can be fixed in tissue.

Figure 11 B and Figure 11 C illustrates the rearview of the first implant 202 and the second implant 402, and it is similar to the view of the implant 202,402 shown in Fig. 6.Therefore, the attachment 102,104 being combined with the first implant 202 and the second implant 402 respectively of the not shown device 100 of Figure 11 B and Figure 11 C, and the first implant 202 and the second implant 402 be shown in deployed configuration.

As shown in Figure 1B illustrates, the spacing of attachment 102,104 can control by cutting off the part 108,110,112 with different length of connector 106.Thus as shown in Figure 1A (its not shown deployable implant), after implant 202,402 is launched, the initial distance between attachment 102,104 can be the first distance d as set by the length of the Part I 108 of connector 106₁, Part I is its shortest part.

Figure 11 B illustrates that the size of pyloric ostium 1102 can be passed through to set the first distance d between implant 202,402₁Being limited at first, it can be same or about with the spacing of attachment 102,104.Also as shown in Figure 1A, the first distance d₁Set by the Part I 108 of connector 106.Therefore, the length of the shortest part of the connector 106 of device 100 can be used to define the initial desired distance between the first attachment 102 and the second attachment 104, it is thus determined that the shrinkage degree of pyloric ostium or other body orifice.Such as when described technology is used to shrink the pyloric ostium 1102 as shown in Figure 11 B and Figure 11 C, the size (such as diameter or other size) of the confined pyloric ostium 1102 of definable lengths of Part I 108, this is smaller in size than the natural size of the pyloric ostium 1100 shown in Figure 11.The size of the pyloric ostium 1102 shown in Figure 11 B is restricted compared with the natural size of the pyloric ostium 1102 shown in Figure 11 A.The size of the pyloric ostium 1102 shown in Figure 11 C increases to some extent relative to the size of the pyloric ostium 1102 shown in Figure 11 B.

In some cases, after body orifice size is limited, it may be desirable to increase body orifice size or recover to its natural size.Such as, when hereinbefore technology is used to restriction pyloric ostium size to help patient's loss of weight and when therefore treatment is fat, pyloric ostium size initial reduction may result in some inconvenience of patient (such as vomiting, nauseating and/or other undesirably symptom).Again such as, pyloric ostium initial reduction can make patient's loss of weight and be likely to be no longer necessary to be maintained at opening initial reduction size.In arbitrary these or other situation any, it may be desirable to increase by the size in limit aperture.

No matter increasing subsequently by pyloric ostium 1102 size of above-mentioned technical limitations is what reason, pyloric ostium 1102 can by cutting off or the Part I 108 of otherwise disrumpent feelings connector 106 expands, as shown in Figure 11 C signal, wherein, Part I 108 is cut into two parts 108a and 108b.As a result, as shown in Figure 11 C, the spacing of implant 202,402 can increase to the second distance d depending on Part II 110 length₂, Part II is time the longest part of connector 106, and it is also as shown in Figure 1B (not shown implant).If because any reason needs to increase pyloric ostium 1102 size, then the Part II 110 of connector 106 can be cut off and the spacing of the first attachment 102 and the second attachment 104 can increase further, for instance increases to distance d as shown in Fig. 1 C (not shown implant)₃.It is undesirable that restriction pyloric ostium 1102 size, then the Part III 112 of connector 106 also can be cut off, thus makes pyloric ostium 1102 recover to its not limited natural size.

Therefore, described embodiment provides simple and adjustable reversible technique for controlling body orifice size.Implant 202,402 is configurable to the puncture orifice during effective closed group is knitted, and it allows to reduce the damage to organizing and lose blood.Connector 106 can be made up of this material, i.e. the end (end such as the part 108a produced because cutting off Part I 108 in Figure 11 C, 108b) of cut-off parts will not damage surrounding tissue.Therefore, body orifice size can control non-invasively.It is undesirable that all parts that the body orifice limit applies constraint and connector 106 are cut off, then implant 202,402 can stay in the body and allow puncturing tissue to heal.As another alternative, owing to nearside alar part and distally alar part are configured to reversibly deployable and can be compressed to mobile to unexpanded configuration, therefore implant 202,402 can be removed from surgical sites.

In certain embodiments, at least one part of connector 106, some parts or all parts and/or whole device 100 can be bioresorbables.Addedly or alternatively, one or more components of implant 202,402 can be bioresorbable.Therefore, after connector 106 is no longer used to restricted orifice size, implant 202,402 can stay surgical sites, until they are completely absorbed or partially absorb, this can extend a period of time being enough to make tissue cure.

Figure 12-15 is shown with device to regulate the additional embodiment of the method in aperture or other hole dimension.Figure 12 schematically shows the pylorus 1100 with pyloric ostium 1102.In the embodiment shown, the device 900 of Fig. 9 is illustrated as the non-limitative example being used for limiting pyloric ostium 1102 size.

As it can be seen, device 900 can use the first implant such as implant 802 (Fig. 8) to be anchored to tissue at pyloric ostium 1102 at position 1024 place.Be combined as it has been described above, device 900 can pass through the first attachment (attachment 901 such as Fig. 9) with implant 802.After device 900 is anchored at the position 1024 of pyloric ostium 1102 side, the second deployable implant 1202 can be held by second attachment (attachment 909 such as Fig. 9) of device 900 and pulling force can be applied on device 900 so that pyloric ostium size reduction.As shown in figure 12, device 900 can be fixed to tissue by expansion the second implant 1202 at position 1206 place of the opposite side of pyloric ostium 1102 subsequently.Implant 1202 can similar to implant 802 (the second implant 402 as shown in figures 2-6), or it can be other suitable implant any.

If needing to increase its size subsequently after pyloric ostium 1102 size is limited at first, then device 900 can be used for regulating the spacing of the first implant 802 and the second implant 1202.As described in above in association with Fig. 9, device 900 can be cut off along the first bridge part 905 of ridge 902, if pyloric ostium 1102 size need not be limited, then device 900 can be cut off further along the bracket 906 forming the second bridge part.

The more than one device being configured to regulate body orifice size according to above-mentioned technology can be used in certain embodiments.Described device can have any suitable configuration and can so select, and makes port size can be incrementally increased after being shunk at first.For pylorus, this can allow more vernier control can be delivered to the food of the certain size of small intestinal from stomach, and therefore this help more accurately to regulate gastric emptying rate.Additionally, the anatomical structure of patient and various situation are likely to need to be placed around more than one device at pyloric ostium.Again such as, when using first device to make pyloric ostium shrink and determining the further size reduction of needs, the second device can be implanted to shrink pyloric ostium further in a suitable manner.

Therefore, Figure 13 is shown with more than one device to regulate an embodiment of the method for pyloric ostium 1102 size.As it has been described above, single implant can be used for more than one device as herein described is anchored to tissue.Thus in the embodiment of Figure 13, single first implant 1301 can be used at position 1304 place of the side of pyloric ostium 1102, device 900 and 1300 being anchored to tissue simultaneously.In this embodiment, device 1300 is shown as having the configuration identical with device 900.But device 1300 can have any suitable configuration, they can be different from the configuration of device 900.Device 900,1300 can be delivered into implantation site 1304 in any way as suitable, for instance is combined with the first implant 1301 by means of they corresponding attachments.In the shape of delivery components that at least one in device 900 and 1300 is configured to be adapted to be connected to the first implant 1301 near-end and/or the embodiment of size, this device may be installed in delivery components.

As further shown in fig. 13, available corresponding second implant 1202,1302 of device 900,1300 being anchored at same position 1204 place of the side of pyloric ostium 1102 by the first implant 1301 is fixed to tissue at corresponding diverse location or site 1306,1308, and this position or site are at the opposite side of pyloric ostium 1102.Device 900,1300 can position to shrink pyloric ostium 1102 in any way as suitable, if it is desired, can at one or more part place the size of all cut-off pyloric ostium 1102 to increase initial contraction subsequently.

Figure 14 schematically shows the embodiment that the more than one device utilized according to above-mentioned technology regulates the method for pyloric ostium 1102 size.In the embodiment shown, the device 900,1300 that corresponding first and second implants 802,1202 (device 900) and 1302,1402 (devices 1300) are all fixed to pyloric ostium 1102 surrounding tissue is utilized to can be used for shrinking pyloric ostium 1102.As shown in figure 14, first implant 802,1302 can be used for relevant position 1404, the 1408 place's anchor 900,1300 in the side of pyloric ostium 1102, and the second implant 1202,1402 can be used for relevant position 1406,1410 place's anchor 900,1300 of the opposite side at pyloric ostium 1102.

It will be understood to those of skill in the art that device 900,1300 can be any kind of device, including the device with various configuration.In addition, it will be understood to those of skill in the art that, device 900,1300 may be positioned to extend across pyloric ostium along pyloric ostium diameter, or location is to regulate its size, as described herein in other position any (as along its any strand tissue) of pyloric ostium 1102.Figure 15 schematically shows another embodiment of the method utilizing multiple device adjustment pyloric ostium size.In this embodiment, as shown in figure 15, device 900,1300 can be positioned so that they extend across pyloric ostium 1102 in cross mode.As shown in figure 15, utilize in relevant position 1404,1,406 first and second implants 802,1202 that device 900 is fixed to tissue, utilize in relevant position 1408,1,410 first and second implants 1302,1402 that device 1300 is fixed to tissue.

Device 900,1300 can implanted in any order and device 1300 can be positioned on above device 900, otherwise or.Additionally, device 900,1300 can with they in arbitrfary point cross one another mode implanted, as implant these devices cross mode, be only illustrated in fig .15 by non-limitative example.

It should be understood that any amount of device (as two, three or more) can by any way in tissue near implanted pyloric ostium and be used for regulating its size.This device implantable is so that adjustable ground keeps any suitable distance between the opposite side of pyloric ostium.Implantable more than one device extends across the multi-form of pyloric ostium with what form the connector of this device.It should also be understood that Figure 12-15 only illustrates and illustrate that device 900,1300 such as has comparable conformation because there is other configuration, the device that includes various configuration can be attached to use or substitute use.As another modification, device can be delivered to implantation site by any way and be fixed to tissue, uses any suitable deployable implant.

Figure 16 A-16C illustrates the embodiment of the method that implant 1600 is delivered to implantation site 1602, stable at implantation site 1602 or fixing organization the method especially for the delivery of implant 1600.Implant 1600 can be associated with any device as described herein (such as device 100,700,900,100), and it is not illustrated in Figure 16 A-16C.In the embodiment shown, implant 1600 can be used for controlling pyloric ostium 1604 size, it will be apparent, however, to one skilled in the art, that the size of other opening any can be controlled by described mode.Implant 1600 can be similar to any implant 202,402 and 802 (Fig. 2-6 and Fig. 8), or it can be configured for other device any being fixed to tissue.

As shown in Figure 16 A-16C with the unexpanded configuration of implant 1600 (as before launching its nearside alar part and distally alar part) deliver it to the method for implantation site 1602 can include grasping and stable with treat the portion of tissue of site vicinity that punctured by implant 1600 far-end.As shown in Figure 16 A, the available suitable grasping apparatus 1606 contiguous pyloric ostium 1604 of grasping and portion of tissue farther from pyloric ostium 1604 compared with treating puncture site.It should be understood that the tissue of other position in the contiguous site treated and punctured by implant 1600 can be grasped.In the embodiment shown, grasping apparatus 1606 (such as clamp, tweezers or other apparatus) includes can curve inwardly distally jaw 1608A, 1608B of organizing therebetween with crawl.But grasping apparatus 1606 can be configured for grasping tissue and any suitable instrument that can operate in any way as suitable.

No matter used grasping apparatus specifically which kind of configuration, when with this apparatus gripping portion tissue, treat that the tissue of the site punctured by implant 1600 can be tightened up and stably to help implant to deliver.In addition, when using grasping apparatus 606 to be held in place by crawled tissue, it is in the implant 1600 of unexpanded configuration to may utilize suitable delivery apparatus (not shown) and be delivered to tissue, so that remote (front) end of implant 1600 penetrates tissue.Subsequently, removable grasping apparatus 1606.Or it can stay implantation site, until the nearside alar part of expansion implant 1600 and distally alar part and implant 1600 are discharged from delivery apparatus.In other embodiments, whenever grasping apparatus 1606 can being removed from surgical sites during implant 1600 is launched.

Figure 16 B illustrates that available stopping means 1612 keeps the embodiment of tissue in place.As indicated, stopping means 1612 can forward (as distad) through pyloric ostium 1606 so that the distal flex part 1614 of stopping means 1612 is positioned at the opposite side of tissue wall treating to be punctured by implant 1600.After positioner 1612 by this way, it can be pulled (such as proximad) subsequently and recline pyloric canal or sphincter to thereby aid in the tissue at fixing implantation site 1612 place.Stopping means 1612 can be any suitable device.Therefore, although be illustrated that T-shaped device, but stopping means 1612 can have other configuration.As shown in fig 16b, stopping means 1612 can have at least one surface character such as barb 1616 or other punctures feature (such as tooth, fork, nail etc.), and it can help to stabilizing tissue and prevents it mobile during implanted thing 1600 penetrates.Stopping means 1612 can in implantation site resident any suitable time period.Such as, removable stopping means 1612 after the distally alar part of implant 1600 and nearside alar part and implant 1600 are discharged is being launched from delivery apparatus.

Such as Figure 16 C another embodiment being schematically shown, suitable aspirator 1620 can be used for grasping site 1622 surrounding tissue treating to be punctured by implant 1600.Aspirator 1620 can be configured for any appropriate device producing and keeping suction.When using aspirator 1620 to keep suction, the implant 1600 being in unexpanded configuration can be pushed to tissue so that by implant 1600 far-end piercing tissue.Removable aspirator 1620 after the nearside alar part and the expansion of distally alar part of implant 1600 and before or after implant 1600 is discharged from delivery apparatus.It will be understood to those of skill in the art that the device 1606,1612,1620 of Figure 16 A-16C is only exemplified and can use any kind of device at implantation site place fixing organization to help implant is sent into tissue.

No matter what configuration device used is, causes the described process of pyloric contractions can postpone gastric emptying, therefore causes satietion ahead of time.Described technology for controlling the such as deep and remote door size of body orifice can be used for treatment needs its object.As used herein object can be mammal, for instance people, non-human primate, horse, sheep, cat, Canis familiaris L., cattle, pig or other mammal.Such as, object can be diagnosed as obesity or with the human patients of overweight other relevant disease or animal.Object on the feed after can experience to reduce early than the appetite occurred under normal circumstances and feel and be satiated with food.So, the dietary behavior of object can be changed, and this may result in reduction food consumption, ultimately results in and loses weight.

Those skilled in the art will envision that the further characteristic of the invention based on above-described embodiment and advantage.Therefore, the present invention is by specifically shown and described restriction, except appended claims shows.The full text of all publications and references cited herein is clearly quoted to be incorporated herein.

Claims

1. control a device for the size in aperture in health, including:

First attachment, it is shaped as and is combined with the first deployable implant；

Second attachment, it is shaped as and is combined with the second deployable implant；

Connector, it is connected between described first attachment and the second attachment, and described connector includes:

Part I, it has the first length, so that described first attachment and the second attachment keep first distance, and

Part II, it has the second length more than described first length, and wherein said Part I is configured to cut-off so that described first attachment and the second attachment keep second distance, and described second distance is more than described first distance.

2. device according to claim 1, wherein, at least one in described first attachment and the second attachment includes ring.

3. device according to claim 1 and 2, wherein, described first attachment includes being formed the first ring in the first end of described connector, and described second attachment includes forming the second ring in the second end of described connector.

4. the device according to claim 1,2 or 3, wherein, described connector includes making described first attachment and the connected elongated ridges of the second attachment, described Part I includes a part for described elongated ridges, and described Part II includes the opposite end being connected to described elongated ridges at the opposite end of described Part I.

5. according to the device one of Claims 1-4 Suo Shu, wherein, described Part I is positioned between the opposite end of the Part II of described connector.

6. according to the device one of claim 1 to 5 Suo Shu, wherein, described connector also includes Part III, described Part III has the 3rd length more than described second length, described Part II is configured to cut-off so that described first attachment and the second attachment keep at a distance of the 3rd distance, and described 3rd distance is more than described second distance.

7. control a system for the size in aperture, including:

First implant, it is configured in tissue to be implanted；

Second implant, it is shaped as in tissue to be implanted；

Connector, it has the first end being connected to described first implant and is connected to the second end of described second implant, and described connector includes:

First bridge part, it extends and has the first length between described first end and the second end, and described first bridge part is shaped as described first implant of maintenance and the second implant first distance, and

Second bridge part, it extends and has the second length more than described first length between described first end and the second end, and described second bridge part is shaped as described first implant of maintenance and the second implant second distance；

Wherein, described first bridge part is configured to cut-off to allow described first implant and the second implant from mobile at a distance of described second distance at a distance of described first distance.

8. system according to claim 7, wherein, described connector includes at least one ring for slidably receiving one of described first implant and the second implant being formed thereon.

9. the system according to claim 7 or 8, wherein, described connector includes forming the first ring for slidably receiving described first implant on its first end, and described connector includes forming the second ring for slidably receiving described second implant on its second end.

10. the system according to claim 7,8 or 9, also include the 3rd bridge part, described 3rd bridge part extends between described first end and the second end and has the 3rd length more than the second length, described 3rd bridge part is configured to keep described first implant and the second implant at a distance of the 3rd distance, wherein along with described first bridge part is cut off, described second bridge part is shaped as cut-off to allow described first implant and the second implant to move at a distance of described 3rd distance from a distance of described second distance.

11. according to the system one of claim 7 to 10 Suo Shu, wherein, described first bridge part is positioned between the opposite end of described second bridge part.

12. the method controlling the size of body orifice, including:

The first position of the first side in aperture is by the first deployable implant implanting tissue；

The second position of the second side in described aperture is by the second deployable implant implanting tissue, thus the first bridge part of the connector extended between described first implant and the second implant keeps described primary importance and second position first distance；With

Cutting off described first bridge part, so that the second bridge part of described connector keeps described primary importance and second position second distance, described second distance is more than described first distance.

13. method according to claim 12, also include, after cutting off described first bridge part, cut off described second bridge part, so that the 3rd bridge part of described connector keeps described primary importance and the second position at a distance of the 3rd distance, described 3rd distance is more than described second distance.

14. method according to claim 13, also include, after cutting off described second bridge part, cut off described 3rd bridge part, thus described connector is not kept at the distance between described primary importance and the second position in described aperture.

15. according to the method described in claim 12,13 or 14, wherein, implant the first implant and include launching the nearside spademan of described first implant and distally spademan to engage tissue therebetween, implant the second implant and include launching the nearside spademan of described second implant and distally spademan with joint tissue therebetween.

16. according to the method one of claim 12 to 15 Suo Shu, wherein, by corresponding first attachment and the second attachment, described connector is combined with described first implant and the second implant.

17. according to the method one of claim 12 to 16 Suo Shu, together with described connector, described first deployable implant being delivered to body orifice before being additionally included in implantation, described connector is connected to described first deployable implant and is arranged in the delivery rod being connected to described first deployable implant.

18. according to the method one of claim 12 to 17 Suo Shu, it is additionally included in the 3rd position in described aperture by the 3rd deployable implant implanting tissue, thus the first bridge part of the second connector extended between described second implant and the 3rd implant keeps the 3rd distance between the described second position and the 3rd position.